FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pounce Thrombectomy System
K Number: K231022
·
Decision Jun 12, 2023
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
11
Review Days
63
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Basic Information
- Device Name
- Pounce Thrombectomy System
- K Number
- K231022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surmodics,Inc.
- Date Received
- April 10, 2023
- Decision Date
- June 12, 2023
- Product Code
- QEW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | FDA class 2 | Cardiovascular |
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Other Clearances by Surmodics,Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252227 | Pounce(TM) Sheath | Sep 24, 2025 | Substantially Equivalent |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Sep 11, 2024 | Substantially Equivalent |
| K232647 | Microcatheter | Sep 29, 2023 | Substantially Equivalent |
| K231828 | Pounce Sheath | Sep 7, 2023 | Substantially Equivalent |
| K221886 | Sublime Microcatheter | Oct 14, 2022 | Substantially Equivalent |
| K220501 | Pounce Thrombectomy System | Mar 23, 2022 | Substantially Equivalent |
| K211492 | Pounce Thrombectomy System | Jul 30, 2021 | Substantially Equivalent |
| K192814 | Pounce Thrombus Retrieval System | Sep 21, 2020 | Substantially Equivalent |
| K190644 | Guide Sheath | Apr 18, 2019 | Substantially Equivalent |
| K173560 | Microcatheter | Jan 12, 2018 | Substantially Equivalent |